Kornimate/medical-research-clean huggingface dataset:
memed bv® test evaluation in adult emergency department patients

Conditions: Respiratory Infection; Respiratory Infections in Old Age; Respiratory Infection Virus; Respiratory Infection Bacterial

Summary: the goal of this observational study is to compare the results of a serum biomarker called the memed bv®, which is approved to help differentiate between bacterial and viral respiratory infections, to clinical diagnoses of adult emergency department patients presenting with recent fever and signs or symptoms of a respiratory infection. active participation is completed during the emergency department visit and includes drawing blood, obtaining a sputum sample, and answering survey questions.

the memed bv® is a diagnostic test newly approved by the fda to assess the likelihood of bacterial vs. viral respiratory infections based on protein biomarkers in blood. this study aims to identify the level of agreement between the results of the memed bv® (bacterial/viral) and the standard of care treatment received by the participant (e.g. antibiotics for patient diagnosed with bacterial pneumonia) in order to see if implementing the memed bv® into standard clinical care would potentially change diagnosis.

Eligibility criteria:
inclusion criteria: * adults presenting to the emergency department * subjective or objective fever within the past 7 days * signs or symptoms of upper or lower respiratory tract infection within the past 7 days exclusion criteria: * prisoner * suspicion and/or confirmed diagnosis of infectious gastroenteritis/colitis * active inflammatory disease * congenital or acquired immune deficiency * chronic fungal or parasitic infection * infection with human immunodeficiency virus (hiv) * hepatitis b virus (hbv) * hepatitis c virus (hcv) * infection with active tuberculosis (tb) * significant trauma or burns in the last 7 days * patients that have undergone major surgery in the last 7 days * pregnancy * active malignancy
moderated hypofractionated online adaptive radiotherapy in cervical cancer

Conditions: Cervical Cancer; Adaptive Radiotherapy

Summary: the most common external beam radiotherapy fractionation scheme for cervical cancer is 45-50.4 gy delivered in 25-28 fractions. however, prolonged treatment duration can lead to insufficient availability of medical resources. we hope to assess the safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with brachytherapy in patients with cervical cancer in a multicenter study.

this is a multicenter, non-inferiority, phase 3, randomized controlled study. this study investigates the role of moderated hypofractionated online adaptive radiotherapy by randomizing patients to this experimental regimen versus the standard of treatment.the purpose of this study is to access safety and efficacy of moderated hypofractionated online adaptive radiotherapy in combination with high-dose-rate brachytherapy in patients with cervical cancer, which based on the previous research (nct05994300).

Eligibility criteria:
inclusion criteria: 1. the patient is fully voluntary and has the capacity for autonomy, signing the informed consent form 30 days prior to enrollment 2. age ≥18 and ≤75 years 3. figo stage ib-iiib cervical cancer; iiic1 (lymph node metastasis ≤2 cm, without common iliac lymph node metastasis) 4. pathologically diagnosed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma 5. concurrent weekly cisplatin therapy ± immunotherapy 6. able to undergo brachytherapy 7. ecog performance status of 0-1, with an expected ability to tolerate lying flat for half an hour. exclusion criteria: 1. patients who have undergone cervical cancer surgery, excluding pelvic lymphadenectomy or pelvic lymph node dissection, or cervical conization 2. figo stages ia, iiic2, iva, or ivb 3. figo stage iiic1 with lymph nodes \>2 cm, or with common iliac lymph node metastasis 4. history of prior abdominal or pelvic radiotherapy 5. pregnant or breastfeeding women 6. patients with active infections or fever 7. other severe diseases that may significantly affect clinical trial compliance, such as unstable heart disease, kidney disease, chronic hepatitis requiring treatment, poorly controlled diabetes, or mental disorders.

Keywords: cervical cancer moderated hypofractionated radiotherapy adaptive radiotherapy randomized controlled trial
a controlled-study on the effect of a combination of fenofibrate and metformin on weight loss and weight loss-maintenance, in obese patients.

Conditions: Obesity

Summary: to investigate the effect on body weight of a combination fenofibrate and metformin on top of a moderate balanced calorie-deficit diet.


Eligibility criteria:
inclusion criteria: * both genders, bmi ≥ 30 kg/m² and \<40 kg/m². exclusion criteria: * known abnormal thyroid hormone levels, or high thyroid stimulating hormone (tsh) level.

Keywords: weight loss and diet.
multiple myeloma (mm) quality of life (qol) study

Conditions: Multiple Myeloma; Quality of Life; Symptom, Behavioral

Summary: the main purpose of this study is to examine differences in quality of life and psychological distress for both multiple myeloma patients receiving treatment and their caregivers and to assess patient and caregiver prognostic understanding (understanding of the likely course of a disease over time) of multiple myeloma to guide development of more personalized treatment plans. this study looks to further understand quality of life changes throughout multiple myeloma therapy for both patients and caregivers to help determine ways to improve patient and caregiver understanding of illness and in turn, tailor customized treatment that best aligns with patient preferences. the study will use a series of questionnaires to measure quality of life, mood, coping strategies, and prognostic understanding.

this research study's procedures include screening for eligibility, participant designation of a caregiver and a series of questionnaires. - it is expected that about 180 people undergoing treatment for multiple myeloma and up to 180 of their caregivers will take part in this research study. -- the questionnaires are completed one time only and measure quality of life, mood, coping strategies, and prognostic understanding and can be completed in the hospital, clinic, over the email, or telephone with assistance provided as needed.questionnaires take approximately 20 minutes to complete.

Eligibility criteria:
inclusion criteria: patient eligibility criteria: * adult patients (greater than 18 years) receiving active therapy for mm. * for patients with newly diagnosed mm, patients are eligible while undergoing induction therapy prior to received autologous stem cell transplant but not after. * ability to read questions in english or willing to complete questionnaires with the assistance of an interpreter. caregiver eligibility criteria: * adult (greater than 18 years) relative or a friend of a patient who agrees to participate in the study whom the patient identified as living with them or having in-person contact with him or her at least twice per week. * ability to read and respond to questions in english or to complete questionnaires with minimal assistance of an interpreter exclusion criteria: * patient exclusion criteria: * patients receiving maintenance therapy only. * significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the study.

Keywords: multiple myeloma quality of life symptom, behavioral
to compare the efficacy, pharmacokinetics and safety between ct-p13 and china approved remicade when co-administered with methotrexate in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to demonstrate that ct-p13 is equivalent to china-approved remicade at week 14, in terms of efficacy as determined by clinical response according to the change from baseline in disease activity.


Eligibility criteria:
inclusion criteria: * has a diagnosis of rheumatoid arthritis * has active disease as defined in das28 criteria exclusion criteria: * has a history of tuberculosis (tb) or a current diagnosis of tb * has previously received a biological agent * has previously received a tumor necrosis factor alpha (tnf α) inhibitor * allergies to any of the excipients of infliximab or hypersensitivity to murine and/or human proteins or immunoglobulin products * pregnant or lactating
effect of the enhanced summer food service program on schoolchildren

Conditions: Pediatric Obesity

Summary: convergent findings from several studies document that children, especially those who are already overweight or obese or from racial / ethnic minority groups, are at risk for accelerated weight gain during the summer months. therefore, this project is comprised of three separate community-based interventions designed to increase access to healthy meals and physical activity opportunities to minimize excess summer weight gain in elementary school children from a diverse, low-income rhode island community. specifically, we will complete a quasi-experimental study in which we will design and deliver a physical activity intervention in conjunction with the summer food service program (sfsp) to 50 children living in a low-income, urban community. we anticipate that the addition of physical activity programming to the sfsp, a federal program funded by the usda which reimburses states for serving lunch meals to children during the summer in communities where at least 50% of students are eligible for free or reduced-price school meals, will increase both the acceptability and effectiveness of the sfsp and affect 1) physical activity levels, 2) sedentary behavior, and 3) diet quality. the primary outcome (change in bmi z-score) will be compared between the 50 kids enrolled in the active intervention and 50 children enrolled in the control condition, both recruited from the same community.


Eligibility criteria:
inclusion criteria: * low-income (defined as qualifying for free or reduced-price meals as part of the national school lunch program) * ages 6-12 years * ability of child to speak, read and write english (for purposes of assessment and intervention) * parent/guardian involvement * agreement to study participation * intent to participate in the sfsp in the upcoming summer exclusion criteria: * medical condition that would interfere with participation in physical activity * enrolled in a camp or other physical activity based summer program.

Keywords: summer diet physical activity sedentary behavior low-income
the sbar effect on safety attitudes in the perinatal department

Conditions: Fetal Distress

Summary: the aim of this study is to analyze the impact of sbar by the saq questionnaire in the perinatal department.


Eligibility criteria:
inclusion criteria: * all physicians and nurses in the perinatal department exclusion criteria: * nil

Keywords: sbar, saq, team resource management
the point of view of hematological cancer patients and their loved ones regarding spirituality

Conditions: Hematologic Cancer

Summary: the management of patients with malignant hemopathy is based on comprehensive management. in this context and faced with the various difficulties encountered by cancer patients, the question of spirituality and its experience is central. spirituality refers to the person's attachment to what inspires and gives him foundation, as well as the beliefs, values, and existential experiences associated with it, whether these are religious in nature or not. although the concept has been identified as a resource in the literature and widely treated in an end-of-life context, assessing the needs of patients with hematological cancer and their loved ones in terms of spirituality from the initiation of treatment does not has not been developed


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years with a recent diagnosis of hematological cancer (lymphoma or leukemia) and in treatment; * patients who speak and read french; * patients in general condition (physical and mental) judged emotionally and physically fit by the referring nurse to answer the questionnaires; * patients benefiting from a social security scheme, * patients who signed the non-objection form after being informed of the study, family person: * have been designated by the patient as being the loved one they wish to include with them; * aged ≥ 18 years; * fluent in and reading french; * having signed the non-objection form after being informed of the study. exclusion criteria: * patients in recurrence / progress or in remission of cancer; * patients in the terminal phase of the disease. family person: person in the curative phase of cancer
kidney dysfunction in children and young adults who have received methotrexate for acute lymphoblastic leukemia

Conditions: Leukemia; Renal Toxicity

Summary: rationale: gathering information about how often kidney dysfunction occurs in children and young adults receiving methotrexate for acute lymphoblastic leukemia may help doctors learn more about the disease and plan the best treatment. purpose: this research study is looking at kidney dysfunction in children and young adults who have received low-dose or intermediate-dose methotrexate for acute lymphoblastic leukemia.

objectives: * examine the incidence of renal dysfunction in children and young adults being treated for acute lymphoblastic leukemia with low- to intermediate-dose methotrexate. outline: medical charts are reviewed to obtain the following information: gender, age, diagnosis, regimen, day of therapy, renal function, creatinine level, mucositis, skin sloughing, methotrexate level at highest level, and number of days after intravenous methotrexate.

Eligibility criteria:
disease characteristics: * diagnosis of acute lymphoblastic leukemia * receiving low- to intermediate-dose methotrexate or received treatment (chemotherapy and/or radiation) at vanderbilt children's hospital patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: renal toxicity childhood acute lymphoblastic leukemia adult acute lymphoblastic leukemia
obesity treatment with a very low energy diet in mexican adults

Conditions: Obesity; Weight Loss

Summary: clinical practice guidelines recommend behavioral change protocols for obesity treatment, such as the diabetes prevention program, which involves a low-energy diet, physical activity recommendations, behavioral therapy, and frequent visits. weight losses of 7-9% per year have achieve with this type of intervention. however, evidence suggests that a very low-energy diet may reach 10-15% weight loss and conduce superior clinical effects. therefore, the objective will be to evaluate the efficacy of the diabetes prevention program with a very-low energy diet and a low-energy diet on body weight change at four months in mexican adults with obesity. the study will be a randomized controlled trial. participants will be randomized to an intensive lifestyle change program with a very low-energy diet or an intensive lifestyle change program with a low-energy diet. the primary outcome will be a change in body weight. secondary outcomes will be changes in waist circumference, body mass index, total body fat, fat-free mass, abdominal fat, blood pressure, and quality of life. data will be analyzed on an intention-to-treat (itt) using student's t-tests or mann-whitney's u-test. the protocol was performed following the spirit guidelines. ethical approval was obtained from the research ethics committee of the department of medicine of the university of sonora.


Eligibility criteria:
inclusion criteria: * adults (≥18 and ≤55 years of age). * residents of the city of hermosillo, sonora. * bmi ≥ 30 and ≤ 40. * availability of time to participate in the study, including initial and final measurements. * have a device with access to the internet * availability and possibility to acquire the indicated diet * send a report of food consumption for three days exclusion criteria: * being a participant in a weight loss program. * weight loss major than 5% in the last six months. * have type 2 diabetes or hypertension (previous). * use of drugs with an effect on body weight ( steroids, injectable progestins, lithium, valproic acid, carbamazepine, antipsychotics, antidepressants, thiazolidinediones, levothyroxine, metformin, and anorexigenic drugs). * have a history of coronavirus disease with hospitalization or the presence of sequelae that prevent the intervention from being carried out. * have cancer, kidney disease, eating disorders, psychiatric disorder (depression) or other serious diseases, active biliary disease, or known asymptomatic gallstones. * pregnancy or breastfeeding. * use of medications for obesity. * use of illegal substances harmful to health (drugs). * illiteracy.

Keywords: obesity weight loss very low energy diet
a comparison study of bypassing agent therapy with and without tranexamic acid in haemophilia a patients with inhibitor

Conditions: Hereditary Factor VIII Deficiency Disease With Inhibitor

Summary: activated prothrombin complex concentrate (apcc) and recombinant activated factor vii (rfviia) are the only two drugs that are available to treat bleeds in haemophilia a patients with high titer inhibitors. however, management of bleeds in these patients can be challenging due to variation in response and lack of standardized methods to monitor the effect. we hypothesized that significant increase in whole blood clot stability could be achieved when tranexamic acid was given concomitantly with bypassing-agents while thrombin generation remains unaffected. in this prospective crossover study the effect of apcc and rfviia with and without txa on clot stability and thrombin generation capacity (etp) were studied, using thromboelastography (rotem) and thrombin generation assay (tga), respectively. in addition, the risk of thrombosis and disseminated intravascular coagulation (dic) was assessed.

patients receive the first day apcc (75iu/kg) and apcc in addition to txa (20mg/kg orally) the second day. after a 14 days washout period they crosse over using rfviia (90 µg/kg) otherwise the same experimental setup. blood sampling is performed at baseline, 15, 30, 60, 120, 180 and 240 minutes post-treatment.

Eligibility criteria:
inclusion criteria: * haemophilia patients with high titer inhibitors or high-responding inhibitors, aged between 18-65 and no history of aspirin or nsaid use within the last 14 days were eligible for the study. exclusion criteria: * patients with renal failure, liver disease, infected with immune deficiency virus (hiv), platelet count \<150x109/l, acquired haemophilia, ongoing bleeding, hypersensitivity to txa or a history of arterial or venous thrombosis were excluded from the study.
study of skq1 as treatment for dry-eye syndrome

Conditions: Dry Eye Syndrome

Summary: the purpose of this study is to evaluate whether skq1 ophthalmic solutions are safe and effective compared to placebo for the treatment of the signs and symptoms of dry eye syndrome.

multi-center, double-masked, randomized, placebo-controlled study comprising 5 visits over the course of approximately 9 weeks. qualified subjects are randomized 1:1:1 to receive either high dose skq1 ophthalmic solution, low dose skq1 ophthalmic solution, or placebo (vehicle of skq1 ophthalmic solution). the primary endpoints are: change from baseline (visit 2) to visit 5 in corneal fluorescein staining; change from baseline (visit 2) to visit 5 in grittiness symptom

Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent; * have a subject reported history of dry eye; * have a history of use of eye drops for dry eye symptoms ; * ocular discomfort; * schirmer's test score; * have corneal fluorescein staining ; * have lissamine green conjunctival staining ; * have a conjunctival redness; exclusion criteria: * have participated in the previous skq1 ophthalmic solution phase 2 treatment study; * have any clinically significant slit lamp findings at visit 1; * be diagnosed with an ongoing ocular infection or active ocular inflammation at visit 1; * have had any ocular and/or lid surgeries within 6 months of visit 1 or any planned over the study period; * have an uncontrolled systemic disease; * be a woman who is pregnant, nursing or planning a pregnancy; * be a woman of childbearing potential who is not using an acceptable means of birth control; * have a known allergy and/or sensitivity to the study drug or its components ; * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study; * be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of visit 1;

Keywords: dry eye dry eye syndrome skq1 kcs keratoconjunctivitis
sound conduction of infant hips

Conditions: Developmental Dysplasia of the Hip

Summary: the objective of this study is to collect data that will be used to later design a method for the early diagnosis of diagnosis of developmental dysplasia of the hip (ddh).

this will be a prospective study using an acoustic listening technique in combination with a standard clinical examination of ddh. for both the clinical cases and healthy children that are enrolled, that all subjects will have an ultrasound completed for comparison to the use of the studied tuning fork method. the gold standard is pocus (point of care ultrasound as performed by the pediatric orthopedic surgeon). collected data will be compared to pocus as performed by an expert and this is standard of care. healthy subjects will be referred for evaluation and found to be healthy on subsequent us.

Eligibility criteria:
inclusion criteria: * infants included in this study must be born at full term with a gestational age of 0-6 months * infants of both genders will be included * infants must have been screened for ddh. exclusion criteria: * infants born prematurely * infants greater than six months of age. * nonviable neonates and neonates of uncertain viability
imaging the uterine cervix - ultrasighthd™

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of this study is to investigate the performance ability of the ultrasighthd™. the instrument will be assessed on characteristics such as focus quality, ability to image the entire cervix, and illumination. the information gathered from this study will provide data that will be used to determine which settings provide the best imaging outcome for the cervix for a simple screening instrument. further, this information will serve as the foundation in the development of more advanced follow-on imaging devices. the primary objectives of this study are to: * determine if the light source provides sufficient illumination of the cervix. * assess focus and overall image quality. * assess the functionality and ergonomics of the instrument's design.


Eligibility criteria:
inclusion criteria: * healthy female * 18 years old or older * not pregnant * ability to give consent exclusion criteria: * male * less than 18 years old * pregnant or suspected pregnancy

Keywords: cervical intraepithelial neoplasia